Pilot Clinical Assessment of Low-cost Infant Incubator in Monitoring Temperature and Treating Hypothermia in Infants
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|ClinicalTrials.gov Identifier: NCT03965312|
Recruitment Status : Recruiting
First Posted : May 29, 2019
Last Update Posted : September 21, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Neonatal Hypothermia||Device: Continuous temperature monitor Device: Neonatal Incubator Device: Patient monitor||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||
In the first phase of the study, a novel neonatal temperature monitor and a commercially available patient monitor (Philips Intellivue MP30) will be applied to the same infant; results between them will be compared.
In the second phase of the study, infants at risk for hypothermia will be placed in an infant incubator; the accuracy of the temperature sensor, time required for infant to become normothermic, and the proportion of time that the infant remains normothermic will be measured.
|Masking:||None (Open Label)|
|Official Title:||Pilot Clinical Assessment of Low-cost Infant Incubator in Monitoring Temperature and Treating Hypothermia in Infants|
|Actual Study Start Date :||July 31, 2017|
|Estimated Primary Completion Date :||September 30, 2022|
|Estimated Study Completion Date :||September 30, 2022|
Experimental: Temperature monitoring (1) and incubator test (2) groups
In the first (1) phase of the study, the temperature probe and monitor will be attached to infants along with the Philips Intellivue patient monitor. Temperature will be monitored continuously for up to 72 hours.
In the second (2) phase of this study, infants at risk for hypothermia and not eligible for skin-to-skin care will be placed in the incubator.
Device: Continuous temperature monitor
Temperature will be measured using a novel temperature monitor continuously for up to 72 hours. Accuracy (as compared to a commercially available patient monitor) will be evaluated.
Device: Neonatal Incubator
Infants at risk for hypothermia will be placed in a neonatal incubator. Their temperature will be monitored as they are treated. The infant will be treated until the infant is transitioned to skin-to-skin care, discharged, or no longer at risk for hypothermia.
Other Name: IncuBaby
Device: Patient monitor
Temperature will be measured using a commercially available patient monitor.
Other Name: Philips Intellivue patient monitor
- Temperature monitor accuracy [ Time Frame: from time of enrollment until intervention is complete; up to 28 days ]Continuously measured temperature for temperature monitor compared against Philips Intellivue patient monitor
- Temperature of incubator [ Time Frame: from time of enrollment until intervention is complete; up to 28 days ]Continuously measured temperature of incubator
- Temperature of infant [ Time Frame: from time of enrollment until intervention is complete; up to 28 days ]Continuously measured temperature of infant
- Time until normothermia [ Time Frame: from time of enrollment until intervention is complete; up to 28 days ]Time until infant becomes normothermic (36.5-37.5C)
- Proportion of time normothermic [ Time Frame: from time of enrollment until intervention is complete; up to 28 days ]The proportion of treatment time that the infant is normothermic (36.5-37.5C)
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|Ages Eligible for Study:||up to 28 Days (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- The subject is currently being treated at QECH in the neonatal ward.
- An IncuBaby device and study monitor are available for use.
- The subject's caregiver has provided informed consent for their child to participate (consent form attached to this proposal).
Phase II only: the subject is eligible for thermal care in an incubator. If the subject is recommended for KMC, they will not be eligible for participation in this study. To be considered for care with the IncuBaby, infants should be:
- Less than 1000 g
Or > 1000 g but
- Receiving medical interventions such as CPAP, oxygen, phototherapy, or IV
- Unstable, critically ill or surgical conditions
- No mother or caregiver available for KMC
- Mother too sick to provide KMC
- Clinician in charge has decided against KMC as requires closer supervision by nursing staff
- No space in KMC
The subject may be excluded from the study at the clinician's discretion for any reason including potential for skin irritation, cough or other condition that may preclude use of the temperature belt, or concurrent treatments that may require increased patient care. Only subjects eligible for care in an incubator will be enrolled in phase II.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03965312
|Contact: Rebecca Elias, MPHfirstname.lastname@example.org|
|Queen Elizabeth Central Hospital||Recruiting|
|Contact: Rebecca R Richards-Kortum, PhD 7133483823 email@example.com|
|Contact: Queen Dube, MD firstname.lastname@example.org|
|Principal Investigator:||Rebecca Richards-Kortum, PhD||William Marsh Rice University|
|Principal Investigator:||Queen Dube, MD||Kamuzu University of Health Sciences|
Documents provided by William Marsh Rice University:
|Responsible Party:||William Marsh Rice University|
|Other Study ID Numbers:||
|First Posted:||May 29, 2019 Key Record Dates|
|Last Update Posted:||September 21, 2021|
|Last Verified:||September 2021|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Body Temperature Changes